ACPURIS INTENSIVE SPOT TREATMENT

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. - In case of having problems such as red rash, swollenness, itching, stimulationduring usage. - In case of having the same symptoms above on the part you put this product on by direct sunlight.You are banned to use it on the part where you have a scar, eczema, or dermatitis.

Apply to the targeted area (The use of applicator of cosmetic pads is recommended)

ACPURIS
INTENSIVE SPOT TREATMENTsalicylic acid cream

Product Information

Product Type

HUMAN OTC DRUG

Item Code (Source)

NDC:52797-020

Route of Administration

CUTANEOUS

DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Strength

SALICYLIC ACID (SALICYLIC ACID)

SALICYLIC ACID

0.3 mL in 15 mL

Inactive Ingredients

Ingredient Name

Strength

Water

Glycerin

Dimethicone

Butylene Glycol

Arbutin

Packaging

#

Item Code

Package Description

1

NDC:52797-020-01

15 mL in 1 CARTON

Marketing Information

Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

OTC monograph final

part333D

09/01/2010

Labeler - MEDIWAY KOREA CO., LTD.
(557784983)

Registrant - MEDIWAY KOREA CO., LTD. (557784983)

Establishment

Name

Address

ID/FEI

Operations

MEDIWAY KOREA CO., LTD.

557784983

manufacture

Revised: 02/2011

Document Id: a02ebf87-4daa-4c13-a3cf-0d826af3758f

Set id: 03dbf0d6-984d-4bd0-a1ae-8b1286cca3fa

Version: 2

Effective Time: 20110223

MEDIWAY KOREA CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.